Drugs / ANX005
Trials 7
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 12 trials | ||||||
| Phase 1 | NCT04035135 | Jan 2020 → May 2021 | Guillain-Barre syndrome | Annexon, Inc. | Completed | No outcome recorded |
| Phase 1 | NCT03010046 | Dec 2016 → Jun 2018 | — | Annexon, Inc. | Terminated | No outcome recorded |
| Phase 23 trials | ||||||
| Phase 2 | NCT04691570 | Nov 2021 → Jan 2023 | autoimmune hemolytic anemia, warm type | Annexon, Inc. | Completed | No outcome recorded |
| Phase 2 | NCT04569435 | Jan 2021 → Jan 2024 | amyotrophic lateral sclerosis | Annexon, Inc. | Completed | No outcome recorded |
| Phase 2 | NCT04514367 | Aug 2020 → Jan 2022 | Huntington disease | Annexon, Inc. | Completed | No outcome recorded |
| Phase 32 trials | ||||||
| Phase 3 | NCT07020819 | Sep 2025 → Dec 2026 expected | Guillain-Barre syndrome | Annexon, Inc. | Recruiting | No outcome recorded |
| Phase 3 | NCT04701164 | Dec 2020 → Apr 2024 | Guillain-Barre syndrome | Annexon, Inc. | Completed | No outcome recorded |
News releases announcing trial results or a regulatory action · 3
| Date | Issuer | Release |
|---|---|---|
| 2026-08-12 | Annexon, Inc. | Results Annexon Reports Second Quarter 2026 Financial Results, Business Updates and Key Anticipated Milestones annexonbio.com ↗
Early outcomes reinforce the consistency and reproducibility of tanruprubart treatment effect previously demonstrated in Phase 3 and real-world evidence studies. |
| 2026-08-06 | Annexon, Inc. | Results Annexon Reports First U.S. and European Patient Cohort of GBS FORWARD Study Demonstrated Rapid, Positive Clinical Responses in All Tanruprubart Treated Patients Within One Week annexonbio.com ↗ |
| 2026-01-08 | Annexon, Inc. | Regulatory Annexon Submits Tanruprubart Marketing Authorization Application to the European Medicines Agency for Guillain-Barré Syndrome annexonbio.com ↗
Annexon, Inc. (Nasdaq: ANNX), a biopharmaceutical company advancing the next generation platform of targeted immunotherapies aimed at neuroinflammatory diseases that impact nearly 10 million people worldwide, today announced it has submitted a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) for tanruprubart for the treatment of Guillain-Barré syndrome (GBS). |
All press releases naming this drug 3 releases
Evidence & citations 5 cited values
Every value below carries the sentence it was read from. 8 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | ANX005 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT04035135 ↗ |
| Known as | Tanruprubart | ClinicalTrials.gov intervention name — accepted as the source's own label NCT07020819 ↗ |
| Action | Inhibit | “inhibits its function as the initiating molecule of the classical complement cascade” PMID 29202623 ↗ Dec 2017 |
| Modality | Protein / enzyme biologic | “Anti C1q Antibody” NCT04035135 ↗ |
| Route | Intravenous | “ANX005 administered as an intravenous infusion” NCT03010046 ↗ |